MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2016-11-11 for HYPERBARIC OXYGEN CHAMBER 3600E manufactured by Sechrist Industries, Inc..
[59878347]
Sechrist contacted initial reporter (b)(6) on october 13, 2016 to discuss this reported event. Ms. (b)(6) stated troubleshooting was performed via phone with one of our sechrist technicians on december 4, 2015; chamber ran through 5 cycles at varying depths and rates and unable to duplicate error "e301". Ms. (b)(6) stated that on december 7, 2015 someone by the name of (b)(6) (not a sechrist employee) evaluated and repaired the reported device.
Patient Sequence No: 1, Text Type: N, H10
[59878348]
It was reported via medsun#(b)(4): no harm to patient. Treatment was complete when system error "e301" and alarm occurred. Patient safely removed from chamber and transported on the gurney to an adjoining room. Notified the national safety director of an acute and chronic wound care organization. Discussed events with service technician for the manufacturer. Chamber run through 5 cycles at varying depths and rates as advised by the manufacturer without duplication of error. Chamber not removed from unit, however, signage was placed on machine to remove from service until inspected. Device usage problem: device failed (e. G. Broke, couldn't get it to work or stopped working) device usage problem: device malfunction - that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2016-00013 |
| MDR Report Key | 6095048 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2016-11-11 |
| Date of Report | 2016-10-12 |
| Date of Event | 2015-12-04 |
| Date Mfgr Received | 2016-10-12 |
| Device Manufacturer Date | 2010-02-26 |
| Date Added to Maude | 2016-11-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VICTOR ARELLANO |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERBARIC OXYGEN CHAMBER |
| Generic Name | HYPERBARIC CHAMBER |
| Product Code | CBF |
| Date Received | 2016-11-11 |
| Model Number | 3600E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-11 |